Gammagard

"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...

* These values are not included in the computation
of the cumulative reduction of virus since the virus clearance is within
the variability limit of the assay ( ≤ 1.0).
NA Not Applicable. Solvent/detergent treatment does not affect non-lipid
enveloped viruses.
NT Not Tested.

When reconstituted with the total volume of diluent (Sterile Water for Injection,
USP) supplied, this preparation contains approximately 50 mg of protein per
mL (5%), of which at least 90% is gamma globulin. The product, reconstituted
to 5%, contains a physiological concentration of sodium chloride (approximately
8.5 mg/mL) and has a pH of 6.8 ± 0.4. Stabilizing agents and additional components
are present in the following maximum amounts for a 5% solution: 3 mg/mL Albumin
(Human), 22.5 mg/mL glycine, 20 mg/mL glucose, 2 mg/mL polyethylene glycol (PEG),
1 µg/mL tri-n-butyl phosphate, 1 µg/mL octoxynol 9, and 100 µg/mL
polysorbate 80. If it is necessary to prepare a 10% (100 mg/mL) solution for
infusion, half the volume of diluent should be added, as described in the DOSAGE
AND ADMINISTRATION. In this case, the stabilizing agents and other components
will be present at double the concentrations given for the 5% solution. The
manufacturing process for GAMMAGARD S/D (immune globulin) , isolates IgG without additional chemical
or enzymatic modification, and the Fc portion is maintained intact. GAMMAGARD (immune globulin)
S/D contains all of the IgG antibody activities which are present in the donor
population. On the average, the distribution of IgG subclasses present in this
product is similar to that in normal plasma.3

What are the precautions when taking immune globulin (Gammagard)?

See also Warning section.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other immunoglobulin products (such as CMV IgG); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

What are the precautions when taking immune globulin (Gammagard)?

See also Warning section.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other immunoglobulin products (such as CMV IgG); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

What are the precautions when taking immune globulin (Gammagard)?

See also Warning section.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other immunoglobulin products (such as CMV IgG); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

What are the precautions when taking immune globulin (Gammagard)?

See also Warning section.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other immunoglobulin products (such as CMV IgG); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

What are the precautions when taking immune globulin (Gammagard)?

See also Warning section.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other immunoglobulin products (such as CMV IgG); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.